Drill-tap-screw drill guide

ABSTRACT

A surgical drill guide for use with a bone plate having fastener holes oriented at predetermined angles with respect to the plate, the surgical drill guide having at least one alignment drill guiding barrel that is aligned with the respective fastener holes in the bone plate for drilling the holes at the desired range of angles permitted by the plate hole.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of U.S. patent applicationSer. No. 11/255,221 filed Oct. 19, 2005 now U.S. Pat. No. 7,763,029,which is a continuation-in-part of U.S. patent application Ser. No.10/823,215, filed Apr. 12, 2004, now U.S. Pat. No. 7,488,327, thecontents of which are expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to the field of surgical drill guides, andin particular relates to drill guides that may be associated with a boneplate for providing precise alignment of hole forming tools with thebone screw holes of the plate. More particularly, the surgical drillguide assembly provides soft tissue protection and precise alignment ofat least one drill tube with bone screw holes of a bone plate, such asfor example, a spinal bone plate.

BACKGROUND OF THE INVENTION

The use of surgical fixation plates for a variety of orthopedicapplications is widely accepted. The plates are used by surgeons tostabilize, mend, or align a patient's bone as well as alter compressionof patient's bones, and are typically fastened to the bones with aplurality of fasteners, such as, screws that are installed through holesin the plate. Proper orientation and alignment of fasteners and securesurgical fixation of the plate can mitigate some of the potentialcomplications after implantation.

Locking bone plates used in spinal applications must be installed withspecial care, as the plates may be used for long term, intervertebralfixation, bone-fragment fixation, and anterior decompression of vertebraof the spine. The margin for error in spinal surgery is small,particularly because of the sensitivity of the spinal cord and the riskinherent with invasive procedures around the spinal cord. Furthermore,the dimensions of vertebral bone available for setting fasteners arefairly constrained.

Screws, used to secure the plate to the bone, should be properly alignedwith the associated fixation plate hole so that each screw is seatedcorrectly within the plate. Any misalignment of the screw within theplate hole risks tissue damage. In addition, improperly seated screwsmay result in an unstable or insecure connection of the plate to thebony material, thus potentially defeating the usefulness of the plate.Locking plates, in particular, demand precise fastener alignment.

Drill guides are often used to assist the surgeon in aligning the screwswith the plate holes. Drill guides for locking plates attach or abut tothe plate and generally include a guide tube for guiding hole-formingtools, such as a drill bit.

SUMMARY OF THE INVENTION

A drill guide is provided comprising a guide barrel for receiving a bonetool for creating a hole in bone and an alignment assembly associatedwith the guide barrel for aligning the bone tool with a selected firstor second fastener hole of a bone plate. The alignment assembly maycomprise a location post configured to be at least partially receivedwithin a recess in the bone plate. Further, the location post may bepivotable about the bone plate recess to allow the guide barrel to beselectively aligned with the first and second fastener holes. Thelocation post alternatively may be configured to axially lock the drillguide to the bone plate.

The location post may further comprise a plurality of resilient fingerelements configured to frictionally engage the bone plate recess tothereby axially lock the drill guide to the bone plate. The resilientfinger elements also may have at least one ridge configured to engagethreads in the bone plate recess.

The alignment assembly further may comprise a housing having a firstaxial bore configured to slidably receive at least a portion of thelocation post. The location post and housing further each may have adistal end. The location post may have a retracted position in which thelocation post distal end is located a first distance from the distal endof the housing. The location post may also have an extended position inwhich the location post distal end is located a second distance from thedistal end of the housing, where the second length is greater than thefirst length. The alignment assembly further comprising a spring elementdisposed at least partially within a second axial bore in the housing tobias the location post to the extended position.

The guide barrel further may comprise a bore with a bore axis, and adistal plate-engaging end, wherein the distal plate-engaging endcomprises a nose portion configured to be received within the first orsecond fastener hole to align the bore with the bone screw hole.

The nose portion may comprise a conical shape. Further, the housingfirst axial bore and the guide barrel bore forming an acute angletherebetween. Thus, when the location post received within the boneplate recess and the location post is in the extended position, theguide barrel distal end may be located a first distance from the topsurface of the bone plate. Further, when the location post is receivedwithin the bone plate recess and the location post is in the retractedposition, the guide barrel distal end may contact the selected bonescrew hole. In an alternative embodiment, the location post may beaxially fixed to the alignment assembly.

The drill guide may further comprise a handle associated with the guidebarrel, and the handle may be configured to be selectively rotatablewith respect to the guide barrel in a first plane. The first plane maybe substantially perpendicular to the longitudinal axis of the guidebarrel bore. A handle swivel assembly may also be provided having alocked position in which the handle can not rotated with respect to theguide barrel, and an unlocked position in which the handle is freelyrotatable with respect to the guide barrel. The swivel assembly maycomprise at least one non-metallic bearing, and may also comprise adrain hole configured to allow fluid to drain from the assemblysubsequent to sterilization of the drill guide.

A surgical drill guide may be provided comprising a handle, a guidebarrel having a proximal end associated with the handle and a distal endconfigured to engage an inner surface of a fastener hole of a boneplate. The guide barrel further may comprise a bore configured toreceive a bone cavity forming tool. An alignment assembly may beassociated with the guide barrel for aligning the bone tool with aselected first or second fastener hole, the alignment assemblycomprising a location post configured to be at least partially receivedwithin a recess in the bone plate;

The location post may be pivotable within the recess to allow the guidebarrel to be selectively aligned with the first and second fastenerholes so that the tool may be extended through the guide barrel to forma cavity in a bone underlying the selected fastener hole. The locationpost may be configured to axially lock the drill guide to the boneplate. The location post further may comprise a plurality of resilientfinger elements configured to frictionally engage the bone plate recessto thereby axially lock the drill guide to the bone plate. The resilientfinger elements may further comprise at least one ridge configured toengage threads in the bone plate recess. The alignment assembly mayfurther comprise a housing having a first axial bore configured toslidably receive at least a portion of the location post.

The location post may have a retracted position in which a first lengthof the location post is received within the bore and an extendedposition in which a second length of the location post is receivedwithin the bore, wherein the first length is greater than the secondlength.

The alignment assembly further may comprise a spring element disposed atleast partially within a second axial bore in the housing to bias thelocation post to the extended position. The guide barrel further maycomprise a bore with a bore axis, and a distal plate-engaging end,wherein the distal plate-engaging end comprises a nose portionconfigured to be received within the first or second fastener hole toalign the bore with the bone screw hole. The nose portion may comprise aconical shape. Further, the housing first axial bore and the guidebarrel bore may form an acute angle therebetween.

The location post may be received within the bone plate recess so thatwhen the location post is in the extended position, the guide barreldistal end is located a first distance from the top surface of the boneplate. Further, when the location post is received within the bone platerecess and the location post is in the retracted position, the guidebarrel distal end may contact second bone screw hole. Alternatively, thelocation post may be axially fixed to the alignment assembly.

The drill guide further may comprise a handle associated with the guidebarrel, where the handle is configured to be selectively rotatable withrespect to the guide barrel in a first plane. The first plane may besubstantially perpendicular to the longitudinal axis of the guide barrelbore. The swivel assembly may have a locked position in which the handlecan not rotated with respect to the guide barrel, and an unlockedposition in which the handle is freely rotatable with respect to theguide barrel. The swivel assembly may further comprise at least onenon-metallic bearing. The swivel assembly further may comprise a drainhole configured to allow fluid to drain from the assembly subsequent tosterilization of the drill guide.

A drill guide assembly is provided comprising a guide barrel having atool receiving portion comprising a longitudinal bore having a boreaxis, and an aligning assembly portion. An aligning assembly may beprovided comprising a guide barrel engaging portion, a housing and alocation post having a post axis. A bone plate may further be providedcomprising at least two bone screw holes and a positioning recess, andthe positioning recess may be configured to receive at least a portionof the location post, the center of the positioning recess beingseparated from the center of at least one of the bone screw holes by afirst distance. The bore axis may be located a second distance from thelocation post axis, the first and second distances being substantiallyequal so that when the location post engages the bone plate recess, thebore is substantially coaxial with the at least one fixation hole.

The drill guide may further comprise a handle member associated with aproximal end of the guide barrel, and the handle member may be pivotablein relation to the guide barrel.

The guide barrel may have at least one depth stop surface configured tocoact with a corresponding stop surface of a bone cavity forming toolwhen the tool is received within the bore to prevent the tool frompassing completely through the guide barrel bore. The handle further mayhave a locked position in which the handle is rotationally coupled tothe guide barrel, and an unlocked position in which the handle is freelyrotatable with respect to the guide barrel. The handle may furthercomprise a locking button having an actuation end and a locking end, thelocking end having at least one radial projection, the button furtherhaving an unactuated position and an actuated position.

The handle may further comprise a bore configured to slidably receive atleast a portion of the button, the bore further comprising a radialrecess configured to receive the radial projection. A handle extensionmay be provided having a handle engaging end and a guide barrel engagingend, the handle engaging end having at least one radial grooveconfigured to receive the radial projection; wherein when the handle isin the unactuated position, the radial projection engages the radialrecesses of the handle bore and the handle extension to configure thehandle in the locked position. Further, when the handle is in theactuated position, the radial projection may engage the radial recess ofonly one of the handle bore and the handle extension to configure thehandle in the unlocked position.

The location post further may comprise a plate engaging end having aplurality of resilient fingers configured to axially lock the drillguide to the bone plate when the location post is engaged with therecess. The location post plate engaging end may have at least onecircumferential ridge configured to engage a bottom surface of the boneplate when the location post is engaged with the recess.

A drill guide assembly may further be provided comprising a guide barrelhaving a tool receiving portion comprising a longitudinal bore having abore axis, and an aligning assembly portion. An aligning assembly may beprovided comprising a guide barrel engaging portion, a housing and alocation post having a post axis. A bone plate further may be providedhaving at least two fastener receiving holes and a drill guidepositioning recess, the recess configured to receive at least a portionof the location post, the center of the recess being separated from thecenter of at least one of the bone screw holes by a first distance.Further, the bore axis may be located a second distance from thelocation post axis as measured between the distal ends of the guidebarrel and the location post, the first and second distances beingsubstantially unequal so that when the location post engages the boneplate recess, the bore is not coaxial with the at least one fixationhole.

The difference between the first and second distances may be from about0 millimeters (mm) to about 0.8 mm. Alternatively, the second distancemay be about .0.5 mm longer than the first distance.

A method for drilling a hole in bone may be provided, comprising thesteps of: providing a bone plate having at least a first pair offastener receiving holes and a drill guide aligning recess; applying theplate to the bone surface; providing a drill guide having a guide borefor receiving a tool and an alignment mechanism associated with theguide bore and including a location post having a proximal alignmentmechanism engaging end and a distal plate engaging end; inserting theplate engaging end of the location post into the recess in the boneplate; rotating the location post within the recess in the bone plate toalign the guide bore with a first selected one of the pair of fastenerreceiving holes; inserting and advancing a tool through the guide boreto contact the bone surface underlying the selected fastener receivinghole; and applying rotational and/or axial force to the tool to creatinga cavity in the bone underlying the selected fastener receiving hole.

The alignment mechanism may further comprise a spring element to biasthe location post distally axially away from the alignment mechanism,the guide bore further comprising a distal end adjacent the distal endof the location post, the guide bore distal end comprising a conicalnose portion configured to engage an inner surface of at least one ofthe pair of fastener receiving holes, wherein the step of aligning theguide bore with a selected one of the pair of fastener receiving holesfurther comprises engaging the guide bore nose with the inner surface ofthe at least one of the pair of fastener receiving holes.

The method may further comprise the step of rotating the location postwithin the hole, slot, or indention in the bone plate to align the guidebore with the second one of the pair of fastener receiving holes;inserting and advancing the tool through the guide bore to contact thebone surface underlying the second fastener receiving hole; and applyingrotational and/or axial force to the tool to create a cavity in the boneunderlying the second fastener receiving hole. The tool may be an awl,drill or tap.

The method may further comprising the steps of disengaging the locationpost from the recess in the plate to disassociate the drill guide fromthe bone plate, inserting a bone fastener through one of the first andsecond fastener receiving holes and into the cavity in the boneunderlying the fastener receiving hole, and engaging the fastener withthe fastener receiving hole and the bone to fix the plate to the bone.

The drill guide bore and alignment mechanism may be offset from eachother so that when the location post is rotated within the bone platerecess to align the guide bore with a first selected one of the pair offastener receiving holes, the guide bore axis is offset from the centerof the fastener receiving hole.

The method may further comprise the steps of inserting and advancing atool through the guide bore to contact the bone surface underlying theselected fastener receiving hole; and applying rotational and/or axialforce to the tool to creating a cavity in the bone underlying theselected fastener receiving hole comprise creating a cavity having anaxis that is not collinear with the axis of the fastener receiving hole.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred features of the present invention are disclosed in theaccompanying drawings, wherein similar reference characters denotesimilar elements throughout the several views, and wherein:

FIG. 1 is a perspective view of a first embodiment of the free handdrill guide assembly, an exemplary bone plate, and an exemplary drillbit;

FIGS. 2A, 2B and 2C are top, side cross section and end cross sectionviews, respectively, of the bone plate of FIG. 1;

FIGS. 3A and 3B are a side view and cross sectional detail view,respectively, of the drill guide of FIG. 1, while FIG. 3C is a crosssectional view of the drill guide of FIG. 1 engaged with the plate ofFIG. 2A;

FIG. 4 is a cross sectional detail view of an embodiment of the drillguide of FIG. 1 incorporating an alternative plate-retaining feature;

FIGS. 5A and 5B are cross-sectional detail and exploded views,respectively, of the swivel handle mechanism of the drill guide of FIG.1;

FIGS. 6A and 6B are cross-sectional detail and exploded views,respectively, of an alternative embodiment of the swivel handlemechanism of FIGS. 5A and 5B.

FIG. 7 is a cross-sectional view of the guide barrel portion of thedrill guide of FIG. 1;

FIG. 8 is a side view of an alternative embodiment of the guide barrelportion of FIG. 7;

FIG. 9 is a side view of the location post of the drill guide of FIG. 1;

FIG. 10 is a side view of an alternative embodiment of the location postof FIG. 4;

FIG. 11 is a side view of an exemplary drill bit for use with the drillguide of FIG. 1;

FIG. 12 is a side view of an exemplary bone screw for use with the bonefixation plate of FIG. 2A.

FIG. 13 is a side sectional view of the bone fixation plate of FIG. 2A;

FIGS. 14A and 14B are side and cross-sectional detail views,respectively, of an awl for use with the drill guide of FIG. 1;

FIG. 15 is a side view of a tap for use with the drill guide of FIG. 1.

FIG. 16 is a perspective view of a bone plate fixed to adjacent vertebrausing two pairs of bone screws, where the bone screws have been placedin holes drilled off-center of the fastener holes of the plate;

FIG. 17 is a top view of the bone plate of FIG. 2A, illustrating anoffset bone screw hole;

FIG. 18 is a cross-sectional view of the location post of FIG. 10engaged with the plate of FIG. 2A;

FIG. 19 is a perspective cutaway view of an exemplary bone screw engagedwith a bone screw hole of a plate having a locking clip;

FIG. 20A is a perspective view of another embodiment of a drill guideengaging a plate;

FIG. 20B is an enlarged view of the engagement of the drill guide ofFIG. 20A with a plate;

FIG. 20C is a partial cross-sectional view of the drill guide of FIG.20B engaging a plate;

FIG. 21A is a side view of an embodiment of the drill guide of FIG. 20A;

FIG. 21B is a cross-sectional view of the drill guide of FIG. 21A;

FIG. 22 is a side view of another embodiment of a drill guide;

FIG. 23 is a side view of an embodiment of a position pin for use withthe drill guide of FIGS. 20A-22;

FIG. 24A is a perspective view of an embodiment of a drill guide with ahandle;

FIG. 24B is an enlarged view of the embodiment of FIG. 24A, wherein thehandle is detached from the drill guide;

FIG. 25A is a perspective view of another embodiment of a drill guidewith a handle, wherein the handle is detached from the drill guide;

FIG. 25B is an enlarged view of the drill guide and handle of FIG. 25A;

FIG. 26A is a perspective view of yet another embodiment of a drillguide with a handle;

FIG. 26B in an enlarged view of the embodiment of FIG. 26A, wherein thehandle is detached from the drill guide; and

FIG. 26C is an enlarged side view of the drill guide and handle of FIG.26A, wherein the components are transparent for clarity.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, there is shown an exemplary drill guide assembly10, which is adapted for use with a spinal fixation device, such as forexample, a spinal fixation plate 70. An exemplary spinal fixation platemay be that disclosed in co-pending United States non-provisional patentapplication entitled “Bone Plate with Captive Clips, by Duong, et al.,filed Sep. 3, 2003, the entire disclosure of which is expresslyincorporated by reference herein. It is noted, however, that while thedrill guide assembly is disclosed in conjunction with a spinal fixationplate it is contemplated that the drill guide assembly may be used inconjunction with bone plates used on any portion of the body.Alternatively, in some instances the drill guide may be used without abone plate. Drill guide assembly 10 generally includes a handle 20, anoffset handle extension 30, a guide barrel 40, and a plate aligningmechanism 50. In general, to operate the drill guide assembly 10, asurgeon grasps the handle 20 of the drill guide assembly 10 and alignsthe plate aligning mechanism 50 (FIGS. 3A, 3B) with a bone plate 70 suchthat the location post 52 of the plate aligning mechanism 50 is receivedwithin a slot end-hole 72 (FIGS. 2A, 2C) in bone plate 70. When thelocation post 52 is received within the end hole 72, the drill guidebarrel 40 may then be swiveled about the location post 52 to bring thebarrel 40 into rough alignment with one of a pair of bone screw holes74R, L in the bone plate 70. A downward force may then be applied to thehandle 20 to force the nose portion 42 of the guide barrel 40 to engagethe targeted bone screw hole 74R, L. This engagement serves to preciselyalign the guide barrel 40 within the bone screw hole 74R, L to assurethe hole in the bone will be drilled in the desired location and withthe desired trajectory, since the hole will largely control the locationof the bone screw placed therein.

With the nose portion 42 of the drill guide barrel 40 engaged with thetargeted bone screw hole 74R, L, an awl, drill and tap may beindividually and sequentially inserted through the guide barrel 40 toprepare the hole in the bone for receipt of a bone screw. Oncepreparation of the hole is complete, the guide barrel nose portion 42may be removed from the bone screw hole 74R, L, and the guide barrel 40swiveled within the slot end-hole 72 to align with the barrel with theother bone screw hole of the “pair.” The second hole may then beprepared in the same manner as the first. After drilling is complete,the drill guide may be lifted off the plate and similarly aligned withanother “pair” of bone screw holes. Since the location post is notaffirmatively retained within the end hole, unwanted movement of theplate is minimized during removal of the drill guide from the plate.

In an alternative embodiment, illustrated in FIGS. 4 & 10, the platealigning mechanism 50 may have a location post 152 with aplate-retaining feature comprising a plurality of axial slots 1152 whichmay form a plurality of resilient fingers 154. This arrangement mayallow the plate aligning mechanism 50 to axially retain the bone platewhich may allow the surgeon to use the drill guide 10 as a plate holder.As the location post 152 is inserted into the slot end-hole 72 of theplate 70, the fingers 154 are compressed together, causing the themexert an expansion spring force against the inner surface of theend-hole 72 in the bone plate, thereby axially locking the drill guide10 to the plate 70. Although the expansion force may be sufficient toaxially lock the drill guide to the plate, the location post may remainrotatable within the hole 72, thus allowing the guide barrel 40 to beswiveled to align with a pair of bone screw holes 74R, L, as describedwith respect to the previous embodiment.

To increase the locking strength of the location post 152 within theslot end-hole 72 of the bone plate 70, the resilient fingers 154 maycomprise one or more circumferential ridges 1154 which may engage theinner surface of the slot end-hole 72. This arrangement may beparticularly effective where the slot end-hole 72 is threaded, becausethe circumferential ridges may engage a portion of the slot end-holethreads. Further, as illustrated in FIG. 18, an end portion 1155 of eachof the locking post fingers 154 may comprise a circumferential ridgethat may engage an underside surface (FIGS. 13 & 18) of the bone plate70 when the post is engaged with the slot end hole 72.

This locking post arrangement of FIGS. 4 & 10 may eliminate the need fora separate tool to place and hold the bone plate in place within thesurgical site. The remaining features of the drill guide of thisembodiment are the same as that described in relation to the previousembodiment. Thus, once the locking post 152 is engaged with the slot endhole 72, the guide barrel 40 of this embodiment may be aligned within atargeted screw hole 74R, L and used with an awl, tap and drill in thesame manner as the drill guide of FIG. 1. After use, however, the drillguide may be disconnected from the plate by pulling up on the handlewith sufficient force to disengage the resilient fingers 154 from theplate slot end-hole 72.

With reference to FIG. 2A, an exemplary bone plate 70 is illustrated.The plate 70 may have a plurality of “pairs” of bone screw hoes 74R, Ldisposed along the length of the plate, and each “pair” of bone screwholes may correspond to a pair of bone screws used to engage a singlevertebra. The bone screw holes 74R, L may have at least an upper portion174R, L (FIG. 2B) that is conical in cross section, and this portion maybe configured to receive the conical nose portion 42 of guide barrel 40.A slot 76 may be provided between successive bone screw hole “pairs,”and this slot may take the shape of a “dog-bone” (i.e. it may comprise aslot with an expanded portion 72 located at either end). In theillustrated embodiment the expanded portions are circular holes 72 (FIG.2C). Each hole 72 may be configured to receive the location post 52(FIGS. 3A, 3B) of drill guide 10 to couple the drill guide and boneplate. The slot 76 may have a longitudinal axis that is substantiallyparallel to the longitudinal axis “A-A” of the plate 70, and in theillustrated embodiment the slot is also centered on the plate axis. Theinner surface 172 of each end hole 72 may be smooth, threaded or ribbed,and a counterbore 173 may also be provided at the top of the hole toprovide a flat surface for embodiments of the plate 70 in which theplate top surface 78 is curved. The end holes 74 may have parallelsides, or the holes may be fully or partially conical in cross-section.It is noted that the end-holes may be provided in any appropriateconfiguration or combination of configurations known in the art.

As shown in FIG. 3A, the drill guide 10 may have a handle 20 with agripping portion 22 and an extension-engaging portion 24. The grippingportion 22 may assume any appropriate configuration, and in theillustrated embodiment is provided with an elongated ergonometric shapehaving a plurality of surface slots 26 to maximize gripping by the userduring operation. The extension-engaging portion 24 may be configured toreceive the proximal extension 32 of a handle extension element 30 whichitself may have a distal extension 34 that engages the drill guidebarrel 40. The extension-engaging portion 24 of the handle may furthercomprise a swivel assembly 28 to allow the handle 20 to be swiveledabout the extension 30 and the guide barrel 40 during use. Thisswiveling function may allow the user to adjust the rotational positionof the handle 20 with respect to the guide tube 40 to provide the mostconvenient approach of the device to the bone plate 70 and to thesurgical site, and also may allow the handle to be rotated away from thework site once the plate 70 has been placed on the bone and the drillguide 10 has been positioned on the plate. The swivel assembly 28 mayfurther be provided with a selective locking feature to allow the userto lock the handle in a desired rotational position with respect to thehandle extension 30 and guide barrel 40.

Referring to FIGS. 5A-6B, the swivel assembly 28 will be described inmore detail. The handle swivel assembly 28 may comprise a button cam 280having a set of radial detents 282 (FIG. 5B), a cam spring 284, abearing 286, a locking element 288 and a handle sleeve 290. The radialdetents 282 may be configured to engage corresponding sets of detentgrooves 292, 294 (FIG. 5B) formed in the handle proximal extension 32and the handle sleeve 290, respectively. The handle sleeve 290 may haveinner and outer surfaces 296, 298, with the outer surface 298 configuredto be received within a bore 200 in the extension engaging portion 24 ofthe handle 20. The handle sleeve 290 may further comprise an uppershoulder region 300 configured to abut an inner axial stop surface 202of the handle 20. The upper shoulder region 300 may comprise a series ofradially-disposed detent grooves 294 configured to receive radialdetents 282 of button cam 280. The inner surface 296 of the handlesleeve 290 may further be configured to receive the proximal handleextension 32 for sliding rotational movement therein. A bearing 286 maybe provided between the proximal handle extension 32 and the handlesleeve inner surface 296 to facilitate smooth rotational movementbetween the pieces to reduce the amount of force required to rotate thehandle about the handle extension and to reduce wear of the components.The handle sleeve 290 and proximal handle extension 32 may be axiallylocked together by means of a locking element 288 positioned withinrespective radial grooves 306, 308 formed in the sleeve 290 and handleextension 32, respectively. In the embodiment of FIGS. 5A & 5B, thebearing 286 may comprise a sleeve element fabricated from a polymer,such as Teflon, PEEK (polyether-ether-ketone), or other suitable bearingmaterial. Likewise, the locking element 288 may comprise a C-shaped clipformed of Teflon, PEEK or other suitable material. Using non-metallicbearing and locking elements 296, 288 may increase the useful life ofthe swivel assembly which, along with the other components of the drillguide 10, may undergo high temperature steam sterilization after eachuse. This exposure to steam, coupled with the difficulty in completelydrying the swivel assembly components after exposure, may lead tocorrosion of assembly components. In particular, galvanic corrosion ofindividual components may occur where the assembly components are madeof different metals and are not separated by a non-metallic material.Thus, a non-metallic bearing and a non-metallic locking clip may beprovided. It is noted that the use of a non-metallic bearing and lockingclip material may provide the advantage of preventing galvanic corrosionbetween the metallic components of the swivel assembly 28 when thesecomponents are subjected to the high-moisture environment of thesterilization process. Such corrosion is undesirable because it mayreduce the efficiency of the swivel assembly after only a few uses dueto the presence of corrosion particles between bearing surfaces.

To further facilitate minimize the chance for corrosion of the swivelassembly pieces, drain holes 1280, 1032 may be provided in the buttoncam 280 and proximal extension 32, respectively to facilitate drainageof any condensation remaining after sterilization of the drill guide 10.Hole 1032 may exit the handle extension 30 at port 1034, thus providinga drainage path between the top portion of the button cam 280 and thehandle extension 30. High pressure air may also be applied to either endof the drainage path to blow out remaining fluid.

In an alternative embodiment, shown in FIGS. 6A & 6B, the bearing maycomprise a series of balls 306 configured to move within correspondingcircumferential grooves 308, 310 in the handle sleeve 200 and proximalhandle extension 32, respectively. With the balls 306 in place withinthe grooves 308, 310, the handle sleeve 200 may further be axiallylocked to the proximal handle extension 32. To facilitate introductionof the balls 306 into the grooves 308, 310, the handle 20 may have anaxial bore 1312 through which the balls may be loaded between thegrooves 308, 310 once the proximal handle extension 32 has been fitwithin the handle sleeve 200. A set screw 312 may then be threaded intothe bore 1312 to prevent the balls 306 from escaping. The balls 306 maybe made from stainless steel, chrome plated steel, or other metal(coated or uncoated) suitable for use as a bearing material.Alternatively, the balls 306 may be made from a suitable non-metallicmaterial, such as a polymer (e.g. ultra-high molecular weightpolyethylene). The swivel assembly of this embodiment further mayincorporate a drain hole arrangement similar to that described above inrelation to FIGS. 5A and 5B, to reduce or eliminate corrosion of theswivel assembly pieces.

Referring again to FIGS. 5A & 5B, the proximal extension 32 of handle 30may comprise first and second axial bores 316, 318 configured to receivethe button cam 280 and the cam spring 284, respectively. When assembled,cam spring 284 may be positioned within the second bore 316 and may abutthe lower surface 291 of the button cam 280 to bias the button upwardlytoward a top surface 204 of the handle 20. The handle 20 may have asecond bore 206, positioned coaxial with the bore formed by thecircumferential inner surface 296 of the handle sleeve 290, and may beconfigured to receive the button portion 320 of the button cam 280therethrough, so that the upward bias of the cam spring 284 may forcethe button portion 320 up through the handle portion so that itprotrudes above the top surface 204 of the handle 20. Thus, the buttoncam 280 may be conveniently thumb-actuated by the user while a grip ismaintained on the drill guide handle 20.

In the unactuated “neutral” position, the handle 20 is axially andradially locked to the handle extension 30 via the engagement of theradial detents 282 of the button cam 280 with detent grooves 292, 294 ofthe proximal extension 32 and the handle sleeve 290, respectively. Torotationally unlock the handle 20 from the handle extension 30 to allowthe handle to be swiveled with respect to the remainder of the drillguide assembly, button cam 280 is pressed downward against the bias ofcam spring 284. This downward axial movement of the button cam 280within the first bore 316 of the proximal extension 32 may cause theradial detents 282 to move out of engagement with the detent grooves 294of the handle sleeve 290 thus rotationally decoupling the handle 20 fromthe handle extension 30, and allowing handle member 20 to be rotatedwith respect to the handle extension 30. Releasing pressure on thebutton cam 280 causes cam spring 284 to return detents 282 of button cam280 into engagement with detent grooves 294 of handle sleeve 290 toagain prevent rotation of handle member 20 in relation to handleextension 30.

As shown in FIG. 3A, the handle 20 may be offset from drill guide barrel40 by offset handle extension 30, thus allowing greater visibility andaccess to bone plate 70 and the vertebra. Distal extension 34 may bemechanically attached to the proximal portion 44 of drill guide barrel40 at an extension receiving section 144, for example by welding,brazing, a threaded connection, friction fit or pinned connection.Extension receiving section 144 may comprise a bore into which acylindrical portion of distal extension 34 is inserted, or handleextension 30 may be associated with the guide barrel 40 in anyappropriate manner. For example, the distal extension 34 may comprise abore configured to engage at least a portion of the outer surface of theguide barrel proximal portion 44, and which may be attached by welding,brazing, a threaded connection or friction fit. Alternatively, thehandle extension 30 may be formed integrally with the guide barrel 40.

Referring to FIG. 7 an exemplary guide barrel 40 is illustrated. Thedrill guide barrel 40 may have a proximal handle engaging end 44 and adistal plate engaging end 46. The guide barrel may further comprise alongitudinal bore 48 having a bore axis “B-B.” The guide barrel bore 48may be configured and dimensioned to slidingly receive therethrough anumber of bone hole preparation tools, such as an awl, tap and/or drill.The guide barrel bore 48 may comprise a proximal portion 148 having afirst diameter “D1” and a distal portion 149 having a second diameter“D2,” and the first diameter “D1” may be greater than the seconddiameter “D2.” Where the drill guide 10 is used with an awl 90 (FIGS.14A, B), “D1” may be sized to accept a proximal middle portion 92 of theawl, and “D2” may be sided to slidingly accept a distal barrel portion94 of the awl. Furthermore, the guide barrel distal end 46 may have aconical inner surface 1252 configured to receive the conical noseportion 96 of the awl barrel portion 94.

The proximal handle engaging end 44 of the barrel 40 may have an endface 150 that may function as a stop surface for the drill bit 80, whichmay limit the total depth of penetration of the drill tip 88 into thebone, thus limiting the ultimate bone hole to a predetermined depth. Inthe illustrated embodiment, end face 150 may cooperate with shoulder 810on drill bit 80 (FIG. 11) to perform this depth limiting function.

Where the drill guide 10 is used with a tap 100 (FIG. 15), the guidebarrel bore 48 may comprise a stop surface 1250 configured to engage acorresponding shoulder 106 of tap 100. These corresponding stop surfacesmay cooperate to limit the distance which thread tapping surface 104 maypenetrate into the bone hole.

The drill guide barrel distal end 46 may further have a conical noseportion 42 configured and dimensioned to be received within the conicalbone screw holes 74R, L of bone plate 70. In one embodiment, the conicalnose portion may have a taper angle α configured to substantially matchthe taper of the corresponding conical portion 174R, L of bone screwhole 74R, L. Alternatively, the taper angle α may be greater than orless than that of the bone screw hole conical portion 174R, L. It isnoted that any appropriate taper angle α may be provided, as long as thetaper functions to center the guide barrel within the bone screw hole toprecisely align the barrel with the bone screw hole to ensure theappropriately placed and angled hole is drilled in the underlying bone.In one embodiment, the taper angle α of the conical nose portion may beabout 12 degrees. Furthermore, the end surface 460 of the guide barreldistal end 46 may be non-orthogonal with respect to the guide barrelbore axis “B-B,” so that when the conical nose portion of the guidebarrel is received within the bone screw hole, the end surface 460 issubstantially parallel to the underside surface of the bone plate (i.e.to reduce or eliminate the chance that any portion of the guide barrelmight extend through the bone screw hole and contact the underlyingbone). In one embodiment, the angle γ formed between the end surface 460and the guide bore axis “B-B” may be about 85 degrees. Providing anangled end surface 460 further may allow the drill guide conical noseportion 42 to engage a portion of the bone screw hole 74R, L even wherethe conical nose portion 42 is not precisely aligned with the taperedportion 174 of the bone screw hole (i.e. where the axis “B-B” of thedrill guide barrel is not coaxial with the trajectory of the bone screwhole). This may be the case when the surgeon is initially aligning theguide barrel with the bone screw hole, or it may also be where thesurgeon purposely aligns the guide barrel out of alignment with the bonescrew hole trajectory (for example, to align the bone screw with an areaof higher integrity bone than exists at the point directly in line withthe bone screw hole trajectory).

The angle γ may also be selected to ensure engagement between the guidebarrel conical nose portion 42 and the bone screw hole 74R, L only wherethe guide barrel 40 axis and the screw hole trajectory are misalignedwithin a certain predetermined range. Thus, in the illustratedembodiment, a portion of the end surface 460 of the nose portion 42 willengage a portion of the bone screw hole 74R, L only up to apredetermined range of misalignment of about 5 degrees (the complementof the angle between the end surface 460 and axis “B-B”). Thispredetermined range may be selected by adjusting the angle γ to ensurethat the bone screw 740 will not ultimately be inserted too far out ofalignment with the bone screw hole trajectory (since such misalignmentmay reduce the effectiveness of the engagement between the bone screwand the plate). The angled end surface 460 feature thus provides thesurgeon with immediate feedback to ensures the ultimate bone screwalignment will be within the predetermined range (i.e. if the endsurface 460 is engaged with the bone screw hole 74R, L, then the hole iswithin the range; if the end surface 460 does not engage the bone screwhole 74R, L, then the hole alignment is outside the range and should beadjusted).

Corresponding to this conical nose portion 42, the guide barrel bore 48may comprise an internal reduced diameter portion 1252 that has an innerdiameter less than the diameter “D2” of bore distal portion 149, andwhich is only slightly greater than the outer diameter of the flutedportion 84 of drill bit 80 (FIG. 11). This reduced diameter portion 1252of bore 48 may also serve as a stop surface for the tool to prevent thetool from penetrating farther into the bone than desired. The reduceddiameter portion 1252 may also act as bearing surface to support andguide the fluted portion 84 of the drill. It may also serve to reducethe amount of drilling debris drawn up into the drill guide during use.

In an alternative embodiment, shown in FIG. 8, guide barrel 40 may havea distal nose portion 142 having a non-conical end portion. With thisalternative nose design, the guide barrel distal end may not be receivedwithin the bone screw hole, thus the surgeon may not use the bone screwhole to automatically align the guide barrel with the bone screw hole.The surgeon may, however, use one of the cavity forming tools toprecisely align the drill guide barrel with the targeted bone screwhole. For example, when using the awl of FIGS. 14A, B, the awl barrel 94may be placed through the guide barrel 40 until the conical nose portion96 extends beyond the guide barrel distal end 46 and engages the conicalportion 174R, L of the targeted bone screw hole 74R, L. The rotationalposition of the drill guide barrel 40 may then be adjusted to nest thetapered nose 96 of the awl within the conical portion 174R, L of thebone screw hole. The awl tip 98 may then be used to form an entry holethrough the cortex of the bone in the desired location. Thereafter, thedrill 80 (FIG. 11) and tap 100 (FIG. 15) may simply be aligned with theentry hole.

Since the flat-nosed end 142 of the guide barrel is not engageable witha bone screw hole 74R, L, the location post 52 may be fixed within theguide barrel housing 156, rather than being slidable and spring biasedas with the previously described embodiments. The post 52 may be fixedwithin the barrel using any appropriate joining method (e.g. brazing,welding, adhesive), or it may be formed as an integral part of thehousing.

Since the nose portion 142 of the guide barrel of this embodiment doesnot have a reduced-diameter conical nose portion (and thus the attendantreduction in inner bore diameter at the guide barrel nose), the guidebarrel bore may allow placement of a bone screw 740 and screwdrivertherethrough, in addition to the awl, tap and drill of the previousembodiment.

Referring again to FIG. 7, the distal end of guide barrel 40 may furthercomprise a viewing slot 352 disposed in the barrel wall. This viewingslot may be used by the surgeon to visually verify the location of thedistal tip of a tool inserted through the guide barrel (for example, tip88 of drill bit 80). In the illustrated embodiment the viewing slot 352comprises an elongated channel having an axis parallel to the axis ofthe guide barrel bore 48. The viewing slot may, however, assume anyappropriate shape, configuration, or orientation known in the art.

The distal end of guide barrel 40 may also comprise a housing 156 whichencloses a plate engaging mechanism 50. This housing 156 may be formedintegrally with the guide barrel or it may be a separate piece that isattached by welding, brazing, adhesive, etc. The housing 156 maycomprise a bore 158 configured to slidably receive a location post 54 ofthe plate engaging mechanism 50. The bore may have an axis “C-C” thatforms an acute angle β with respect to longitudinal axis “B-B” of theguide barrel. When the drill guide is installed on bone plate 70, theplate engaging mechanism 50 may be oriented so that axis “C-C” issubstantially perpendicular to the top surface 78 of the bone plate 70.Thus, angle β may be the angle at which the awl, tap and drill will beinserted into the bone, and so it may also be the angle at which thebone screws will ultimately be installed in the bone. To ensure properengagement between the bone screw 740 and the screw hole, 74R, L, angleβ may be selected to correspond to the trajectory of the associated bonescrew hole 74R, L in the plate 70, which in an exemplary embodiment isabout 4 degrees.

The housing 156 may further comprise a slot 160 oriented substantiallyparallel to axis “C-C” and configured to receive a pin 162 used toretain location post 54 within the housing 156. This feature will bedescribed in more detail below.

Referring to FIG. 3B, plate engaging mechanism 50 will be described ingreater detail. Plate engaging mechanism 50 is designed to stabilize thedrill guide 10 on the bone plate 70 and to provide a pivot point aboutwhich the guide may be rotated so as to bring the guide barrel 40 intoalignment with a targeted pair of bone screw holes 74R, L, thus allowingtwo bone screw holes to be drilled with only a single placement of thedrill guide on the bone plate.

The plate engaging mechanism 50 may comprise a location post 52 (FIG. 9)configured to cooperate with a slot-end hole 72 of a bone plate tostabilize the drill guide on the bone plate. The location post 52 mayhave a proximal end 522 configured to slide within bore 158 of guidebarrel housing 156 (FIG. 7), and a distal end 524 configured tocooperate with slot-end hole 72 of bone plate 70. A spring element 502may be provided within guide barrel housing 156 and may be configured toengage the location post on its proximal end surface 526 to axially biasthe location post 52 in the distal axial direction (i.e. in thedirection of the bone plate 70). The location post 54 may be axiallyretained within the housing bore by a pin 504 which may be passedtransversely through a bore 528 in the proximal portion of the post 52and which may also engage slot 162 of the guide barrel housing 156 (FIG.7). Thus, when the plate engaging mechanism is assembled, the spring 502may force the location post to move in the axial distal direction untilthe pin 504 abuts the distal most end of the slot 162 in the housing156, whereupon further axial movement of the post 52 is prevented.

The distal end of location post 52 may comprise a nose section 530configured to sit within the slot end-hole 72 of the bone plate 74. Inthe illustrated embodiment, the nose section 530 has rounded sides 532and a flat end 534. In this embodiment, the rounded sides 532 areconfigured to contact the inner surface 172 of slot end-hole 72 to seatthe post within the hole, but without axially retaining the post therein(i.e. lifting the drill guide up off the bone plate will not cause theplate to move upward with the drill guide).

This configuration of the nose section 530 and the slot end-hole 72 mayallow the location post 52 to “toggle” within the hole, thus allowingthe surgeon to adjust the drill guide barrel 40 trajectory slightlywithin the targeted bone screw hole 74R, L while still maintaining theconnection between the location post 52 and the plate end-hole 72. This“toggling” feature may the surgeon to customize the trajectory of thehole (i.e. alter it from the trajectory of the bone screw hole 74R, L)that will be drilled into the bone, thereby customizing the trajectoryof the bone screw that will be placed in the hole. This feature mayprovide the surgeon with an important degree of flexibility the boneunderlying the plate is of varying integrity. For example, where thearea of bone directly in line with the bone screw hole 74R, L is ofsub-standard integrity, a slight adjustment in the guide barreltrajectory (while still maintaining the nose 42 engaged with the bonescrew hole 74R, L) may allow the surgeon the option of placing the hole(and thus the screw) within an immediately adjacent higher integrityarea of bone.

This “toggling” feature may also allow the surgeon greater flexibilityin drilling holes in vertebra that may be difficult to access, such asthe cervical vertebra C1 through C3, and C7. Anterior access to thesevertebra may be partially obstructed by the chin (C1-C3) or the sternum(C7), and thus, it is an advantage to allow the surgeon the option ofadjusting the guide barrel trajectory to avoid the obstruction, whilemaintaining the contact between the plate slot end hole 72 and thelocation post 54.

The nose section may be used with slot end-holes having various innersurface configurations (e.g. smooth, threaded, ribbed, conical, etc.).This configuration minimizes the chance that the bone plate position onthe bone will be affected when the drill guide is disengaged from theplate (e.g. when the drill guide is repositioned on the bone plate toaccess a second pair of bone screw holes).

The spring-biased feature of the location post 52 allows the drill guidebarrel 40 to assume a “neutral” position with respect to the bone plate70 when the location post is received within the slot end-hole 72. Inthis “neutral” position, the nose portion of the guide barrel is axiallyoffset from the top surface of the bone plate 70, and thus may then befreely pivoted about the location post to position the barrel 40 inalignment with a right or left bone screw hole of a targeted bone screwhole pair 74R, L. Final alignment of the guide barrel 40 with the bonescrew hole 74R, L may then be achieved by pressing downward on the drillguide handle 20, thus compressing the location post spring 502, andallowing conical nose portion 42 of the guide barrel 40 to fit preciselywithin the targeted bone screw hole 74. Bone hole preparation tools maythen be introduced through the barrel. Once bone hole preparation iscomplete for the first of the pair, the downward force on the handle maybe reduced, thus allowing the spring 502 to move the drill guide up andaway from the plate 70. The guide barrel may then be pivoted about thelocation post to align with the second bone screw hole of the pair.

An alternative location post design is shown in FIG. 10, in which distalportion 524 comprises a plate-retaining feature, which is illustrated asa plurality of resilient fingers 154 configured to engage the slot-endhole 72 of the bone plate 70. This arrangement may allow the platealigning mechanism 50 to axially retain the bone plate which may allowthe surgeon to use the drill guide 10 as a plate holder. As the locationpost 152 is inserted into the slot end-hole 72 of the plate 70, thefingers 154 are forced together, causing them to exert an expansionspring force against the inner surface 172 of the slot end-hole 72,thereby locking the drill guide 10 to the plate 70. Although theexpansion force may be sufficient to axially lock the drill guide to theplate, the location post remains rotatable within the hole 72, thusallowing the guide barrel 40 to be swiveled to align with a pair of bonescrew holes 74R, L, as described with respect to the previousembodiment.

To increase the locking strength of the location post 152 within theslot end-hole 72 of the bone plate 70, the resilient fingers 154 maycomprise one or more circumferential ridges 1154 which may engage theinner surface of the slot end-hole 72. This arrangement may beparticularly effective where the slot end-hole 72 is threaded, becausethe circumferential ridges may engage a portion of the slot end-holethreads. Further, as illustrated in FIG. 18, the distal-mostcircumferential ridge 1155 of each resilient finger 154 may beconfigured to engage an underside surface 79 of the plate 70, thusproviding an additional axial retention feature between the plate to thedrill guide 10.

As shown in FIG. 11, drill bit 80 may comprise a proximal coupling end802 and a distal drilling end 804. The proximal coupling end 802 may beconfigured to couple to an appropriate source of rotational motion,either hand or powered, and may assume any appropriate configurationknown in the art. The distal drilling end 804 likewise may comprisedrilling flutes 84 configured to drill into bone. Intermediate theproximal and distal ends 802, 804 the drill body 806 may comprise atleast one shoulder region 810 configured to cooperate with an internalshoulder 150 of the drill guide barrel bore 48 to control the maximumdistance which the drill is allowed to advance beyond the nose portion42 of the guide barrel 40. This maximum distance may correspond to amaximum desired drilling depth, and may controlled by locating thecooperating shoulder regions 810, 150 of the drill 80 and guide barrel40 appropriately.

In an alternative embodiment, the drill guide barrel 40 and plateattachment mechanism 50 may be arranged so that the hole drilled in thebone may be slightly longitudinally offset from the center of the bonescrew holes 74R, L located on one end of the bone plate 70. Drilling ahole in the bone which is offset from the bone screw hole 74R, L of theplate 70 may result in the head 742 of the bone screw 740 (FIG. 12)overhanging one side 744 (FIG. 13) of the screw hole 74R, L when thescrew is initially inserted into the hole in the bone (FIG. 16). Thus,as the bone screw 740 is driven into the vertebra, the angled lowersurface 746 of the screw head 742 may contact the side 744 of the screwhole, and as the bone screw 740 is driven further into the vertebra, thescrew head may force the plate 70 to move longitudinally relative to thescrew 740 until the screw is centered within the bone screw hole 74R, L.This arrangement may be used to move adjacent vertebra nearer to eachother simply by tightening the bone screws that are drilled into theoffset holes (i.e. compression of the intermediate disc space may beachieved). To effect such a compression, a first pair of bone screws maybe inserted through a first pair of bone screw holes 74R, L and fullyengaged with the underlying vertebra to lock the plate 70 to the firstvertebra. Thereafter, the drill guide of the present embodiment may beused to prepare two bone screw holes that are longitudinally offset fromthe center of an adjacent pair of bone screw holes in the plate 70. Asecond set of bone screws then may be driven into the offset holes toachieve the above-described longitudinal movement between the plate andthe screws. To achieve the desired offset, the distance between theguide barrel 40 and the guide barrel housing 156 may be varied asappropriate.

As shown in FIG. 17, an exemplary offset bone hole insertion point isindicated as “X,” while the center point of the bone screw hole 74R, Lis indicated as “Y.” The distance from the bone plate slot end-hole 72to the center of the bone screw hole 74R, L is designated “L1,” whilethe distance from the bone plate slot end-hole 72 to the center of theoffset bone hole insertion point “X” is designated “L2.” An axis “D-D”formed by points “X” and “Y” may be oriented substantially parallel tothe longitudinal axis “A-A” of the bone plate 70. A bone screw 740 (FIG.12) inserted into a hole formed at point “X” will, when tightened intothe bone, move toward point “Y” due to the previously describedinteraction of the bone screw head 742 with the side 744 of the fastenerhole 74R, L. This movement of the bone screw 740 along axis “D-D” willalso move the attached bone segment 2002 along axis “D-D” toward theadjacent bone segment 2004, thus drawing the two bone segments closertogether along axis “D-D.”

In the embodiment illustrated in FIG. 16, the bone plate may be attachedto adjacent vertebra 2002, 2004 of the spine such that the plate axis“A-A” may be substantially aligned with the longitudinal axis of thespine. Thus, compression of the disc space 2006 between the adjacentvertebra 2002, 2004, may be achieved substantially along the axis of thespine. Compression of the disc space in a direction substantially alongthe longitudinal axis of the spine may be important for a number ofreasons, including the need to maintain the patient's anatomy in asnormal a post-operative condition as possible. Additionally, where anIntervertebral spacer (e.g. a fusion spacer) has been installed betweenthe vertebral end plates, compression along the spine axis serves toprovide proper initial seating and loading of the spacer between the endplates.

To achieve this compression vector, the guide barrel 40 and locationpost 52 may be configured so that the center of the guide barrel 40distal end 44 and center of the location post 52 may be separated by adistance equal to length “L2” so that when the drill guide barrel isrotated about the location post 52 it may be aligned with offset bonehole insertion point “X.”

In one embodiment, the guide barrel 40 and barrel housing 156 may beconfigured so that the distance between points “X” and “Y” along axis“D-D” is about 0.5 mm, thus allowing approximately 0.5 mm oflongitudinal compression of adjacent bone segments. In one embodiment,the drill guide barrel and housing may be configured so that thedistance between points “X” and “Y” may be from about 0 mm to about 0.8mm, thus allowing longitudinal compression of bone segments of fromabout 0 mm to about 0.8 mm when the fasteners are tightened within theappropriate bone screw holes.

While the bone plate, drill bit, and drill guide assembly are shown anddescribed for use in fixing adjacent vertebra of the spine, it will beappreciated that the drill guide assembly may be utilized with anysuitable bone plate or other structure that may be secured to bone usingbone fasteners. Alternatively, the drill guide may be used without abone plate to guide the drilling of fastener holes in bone at anyappropriate location in the body.

The method of drilling holes in vertebrae with the system disclosedabove will now be described. The surgeon may introduce a bone plate 70through an incision in the patient's skin and move the plate to adesired location on the patient's spine. In an exemplary embodiment, theplate may have at least two pairs of bone screw holes 74R, L configuredto engage two adjacent vertebra in the cervical region of the spine.After the plate has been appropriately placed on the spine, the drillguide 70 may be introduced through the incision and the location post 52may be seated within a slot-end hole 72 associated with one of the twopairs of bone screw holes of the bone plate. The drill guide 10 may thenbe pivoted about the location post 52 to align the guide barrel with thefirst bone screw hole of the targeted pair of bone screw holes 74. Oncethe guide barrel 40 has been substantially aligned with a bone screwhole 74, downward pressure may be applied to the handle 20 to move thenose 42 of the guide barrel into engagement with the bone screw hole,thus precisely aligning the guide barrel with the screw hole 74. Thesurgeon may then sequentially insert, in any combination, an awl, tapand/or drill through the guide barrel bore to prepare a hole in the bonefor receipt a bone screw. Preparing the hole in the bone using the drillguide 10 ensures that the hole is drilled in a vertebra at the properangle coaxial with the fixation hole. After the first bone hole has beenprepared, the drill guide may be rotated within the slot in the boneplate until the drill guide barrel is positioned above the second of thepair of bone screw holes. The process of applying pressure to engage thefixation hole and inserting the drill bit is then repeated. Holescoaxial with other pairs of fixation holes in the plate 70 may then bedrilled by lifting the drill guide off the plate and seating thelocation post 52 in the slot-end hole 72 adjacent the next pair oftargeted bone screw holes.

For embodiments of the drill guide 10 in which the location post 152 hasan axial retention feature (e.g. resilient fingers) to retain the drillguide to the plate, the drill guide may be used to insert the platethrough the incision in the patient and to align the plate at thedesired location on the spine. Furthermore, once a pair of bone screwholes have been accessed and the appropriate holes drilled, a separatingforce must be applied between the drill guide of this embodiment and theplate to overcome the retaining force of the location post.

Additionally, when using the embodiment of the drill guide having aguide barrel without a conical nose portion, the step of pressing theguide barrel into the bone screw hole is omitted, and proper alignmentof the drill guide barrel and the targeted screw hole may be achieved bysimply pivoting the guide barrel into alignment over the screw hole.Alternatively, the user may employ the awl 90 (FIGS. 15A, B) to alignthe guide barrel 40 with the bone screw hole 74R, L. The awl 90 (FIGS.15A, B) may be inserted through the guide barrel 40 so that the taperednose portion 96 of the awl extends beyond the distal end 44 of the guidebarrel and engages the tapered portion 174R, L of the targeted bonescrew hole 74R, L. Once the awl tip 98 has been used to break the cortexof the underlying bone to form the initial entry hole, the drill 80 maythereafter be aligned within the initial entry hole, thus maintainingthe proper drilling location. An exemplary awl may be that disclosed inco-pending United States non-provisional patent application entitled“Spring Loaded Awl,” by Christopher J. Ryan, filed Aug. 19, 2003, theentire disclosure of which is expressly incorporated by referenceherein.

Another embodiment of a drill guide 400 is shown in FIGS. 20A-21B. Asseen in the perspective view of FIG. 20A, drill guide 400 may have anattachment portion 402 for engaging a handle (discussed in detailbelow), a shaft portion 404, and a engagement portion 406 for at leastpartially engaging a plate 450. Drill guide 400 may also have a bore 408extending therethrough, which may be sized to receive a bone screw 410therethrough, in addition to other objects and instruments, such as adrill bit, awl, tap, screwdriver, etc. Plate 450 may have a plurality offixation holes 452, a plurality of drill guide keys 454, and a pluralityof windows 456. Fixation holes 452 may receive a bone screw 410, whichmay be utilized to attach plate 450 to a bone or tissue. Drill guidekeys 454 may assist in aligning and/or securing drill guide 400 relativeto plate 450, as described in detail below. Windows 456 may assist asurgeon in visualizing a body site below plate 450, such as anintervertebral disc space.

FIG. 20B shows an enlarged view of the embodiment of FIG. 20A. As seenin this illustration, engagement portion 406 of drill guide 400 may havea barrel portion 412 and a pin portion 420. Barrel portion 412 may havetapered end portion 414, and may be at least partially inserted into afixation hole 452, as described in detail below. Pin portion 420 mayhave a bore 424 therethrough, in which at least a portion of a positionpin 422 may be received. Pin portion 420 may also have a leading surface421. Shown in more detail in FIG. 20C, position pin 422 may engage adrill guide key 454 of plate 450. Concurrently to this engagement,tapered end portion 414 may be at least partially inserted into anadjacent fixation hole 452. Leading edge 415 (see FIG. 20C) of taperedend portion 414 may sit on the upper surface 461 of a clip 460 withinfixation hole 452. Engagement portion 406 may have at least one channel416 therein, which may create a plurality of resilient fingers 417 whichmay be expandable radially outward to enlarge bore 408 of drill guide400 along engagement portion 406.

FIG. 20C shows a partial cross-sectional view of the embodiment of FIG.20B with a bone screw 410 disposed within fixation hole 452 and inengagement with clip 460. As seen in this illustration, leading edge 415of tapered end portion 414 rests on the upper surface 461 of clip 460,while position pin 422 partially extends into drill guide key 454. Thus,the engagement of position pin 422 to drill guide 454 may serve toprovide a releasable, yet secure connection with plate 450 such thatengagement portion 406 and bore 408 of drill guide 400 may be alignedwith a fixation hole 452 for precise placement of bone screw 410 intofixation hole 452, or insertion of an instrument or object into bore 408and through fixation hole 452. This arrangement may also be beneficialbecause drill guide 400 may not need to be removed from fixation hole452 to insert a bone screw 410 into a fixation hole 452 after the drillguide 400 is used to guide a drill (not shown) through fixation hole 452and into a bone surface below. As leading edge 415 of tapered endportion 414 is positioned on the top surface 461 of clip 460, instead ofcovering clip 460 or otherwise engaging clip 460, a bone screw 410inserted via bore 408 to be inserted into fixation hole 452 may properlyengage clip 460 without interference by drill guide 400. This may bebeneficial, as a surgeon may therefore be able to engage drill guide 400with a plate 450, perform any tapping, awling, drilling, or otherprocedure on a bone surface below plate 450 via a fixation hole 452, andthereafter insert a bone screw 410 (which may properly engage a clip460) into the fixation hole 452 without having to remove or re-positiondrill guide 400 in any way. This advantage may make for more efficientand simpler surgical procedures, in addition to more consistentalignment of objects, instruments, and bone screws 410 via a singlefixation hole 452.

Clip 460 may be disposed in a groove 462 within a plate, and preferablyis comprised of a resilient expandable material that may partiallyexpand and thereafter retract upon insertion of a larger object. Theremay also be a gap 426 between engagement portion 406 and pin portion 420of drill guide 400.

FIGS. 21A-21B show further views of drill guide 400. As seen in the sideview of FIG. 21A and the cross-sectional view of FIG. 21B, bore 408 mayextend completely through attachment portion 402, shaft portion 404, andengagement portion 406 of drill guide 400. As also seen in FIG. 21B, pinportion 420 may have a partial bore 427 instead of a bore 424 completelytherethrough (compare FIG. 20B). Partial bore 427 may have an opening429 at leading surface 421, and may also have an end 428 disposed withinpin portion 420. Both partial bore 427 and bore 424 may be selectivelysized and shaped to receive a variety of position pins 422.

FIG. 22 shows a side view of another embodiment of a drill guide 400.This embodiment has a different attachment portion 402, as compared tothe embodiment shown in FIG. 21A. Handle portion 402 may be varied toaccommodate and/or engage a variety of handles, as shown and describedin more detail in relation to FIGS. 24A-26C.

FIG. 23 shows a side view of an embodiment of a position pin 422. Pin422 may have a leading end 422 a configured to engage a drill guide key454, and a trailing end 422 b configured to be inserted into a bore 424or partial bore 427 of a pin portion 420. Pin 422 may also have anannular ledge 422 c, which, when pin 422 is inserted into bore 424 orpartial bore 427 of pin portion 420, may be situated adjacent to leadingsurface 421 of pin portion 420. Preferably the annular ledge 422 c issized larger than bore 424 or partial bore 427, so as to provide a stopthat may limit the movement of pin 422 within a bore 424 or partial bore427. Pin 422 may also have a tapered surface 422 d, which may partiallyengage a drill guide key 454. Tapered surface 422 d may be beneficial tocreate a frictional relationship between pin 422 and drill guide key454, such that as the cross-sectional size of tapered portion 422 dapproximates the cross-sectional size of drill guide key 454, pin 422 isreleasably, yet securedly disposed with drill guide key 454. Thisembodiment of pin 422 is exemplary, as other sizes, shapes, dimensions,and characteristics are expressly contemplated, and will be appreciatedby those skilled in the art.

FIGS. 24A-24B show an embodiment of a drill guide 400 and handle 600. Asseen in the perspective view of FIG. 24A, and enlarged view of FIG. 24B,handle 600 may have a gripping portion 602 and a connecting portion 604.Connecting portion 604 may have an annular ring 606 having a centralopening 608 having a ridged inner surface 609. Attachment portion 402 ofdrill guide 400 may have an upper ridged portion 470 and a lower ridgeportion 472, with an extension portion 474 extending therebetween. Inuse, annular ring 606 may be lowered onto attachment portion 402, to theextent that ridged inner surface 609 engages lower ridged portion 474,and rests against annular ledge 473, which preferably acts as a stop, asseen in FIG. 24A. Preferably, ridged inner surface 609 and lower ridgedportion 474 may engage in a variety of rotational arrangements, suchthat handle 600 may assume a variety of angulations relative to drillguide 400.

FIGS. 25A-25B show another embodiment of a drill guide 400 and handle620. As seen in the perspective view of FIG. 25A, and enlarged view ofFIG. 25B, handle 620 may have a gripping portion 622 and a connectingportion 624. Connecting portion 624 may have a C-shaped portion 626having an opening 627 and at least one projection 628 disposed on theinner surface 629 of C-shaped portion 626. Connecting portion 624 mayalso have a channel 630 extending from the inner surface 629 of theC-shaped portion 626, and toward gripping portion 622. Channel 630 mayallow C-shaped portion 626 to expand outwards to engage a larger objecttherein. Attachment portion 402 of drill guide 400 in this embodimentmay have upper and lower annular portions 482, 484, with an engagementportion 480 disposed therebetween. Engagement portion 480 may have aplurality of channels 481, wherein a channel 481 may be sized andconfigured to receive a projection 628 of connecting portion 624. Inuse, C-shaped portion 626 of handle 620 may engage attachment portion402 by aligning the opening 627 with the engagement portion 480, andthereafter urging the C-shaped portion 626 toward the engagement portion480, which may expand the C-shaped portion 626 outwards (which may bemade possible by channel 630, described above). As each projection 628becomes aligned with a channel 481, the C-shaped section 626 may snapback into its original form, thereby affixing the handle 620 to drillguide 400. Preferably, upper and lower annular portion 482, 484 aresized to prevent C-shaped portion 626 from sliding off of engagementportion 480. Again, it may be possible to engage C-shaped portion 626with engagement portion 480 at a variety of rotational relationships,thereby providing a variety of possible angular arrangements betweenhandle 620 and drill guide 400.

FIGS. 26A-26C show yet another embodiment of a drill guide 400 andhandle 640. As seen in the perspective view of FIG. 26A, the enlargedview of FIG. 26B, and the transparent view of FIG. 26C, handle 640 mayhave a gripping portion 642 and a connecting portion 644. Connectingportion 644 may have an annular ring 646 with a central opening 648having an inner surface 649. A spring 650 may be disposed along theinner surface 649, and may have a substantially circular shape. Spring650 preferably is flexible. Attachment portion 402 of drill guide 400may have a upper and lower annular portion 492, 494 with a recessedannular portion 490 therebetween. In use, the annular ring 646 ofconnecting portion 644 may be lowered onto attachment portion 402, suchthat spring 650 expands when passed over upper annular portion 492, andcontracts when aligned with recessed annular portion 490. Accordingly,it is preferable that lower annular portion 494 be sized larger than therecessed annular portion 490. Moreover, it may be preferable to positionannular ring 646 such that the lower surface 647 of annular ring 646rests on annular ledge 496 of attachment portion 402, thereby preventingannular ring 646 from traveling farther down attachment portion 402. Aswith previous embodiments of handles 600, 620 described above, handle640 may assume a variety of angular arrangements relative to drill guide400, as annular ring 646 may fit onto attachment portion 402 in avariety of rotational positions.

While the embodiments shown herein generally utilize a clip for engaginga bone screw, it is expressly contemplated that other suitable retentionmechanisms may be employed, as will be appreciated by those of skill inthe art.

While the invention has been shown and described herein with referenceto particular embodiments, it is to be understood that the variousadditions, substitutions, or modifications of form, structure,arrangement, proportions, materials, and components and otherwise, usedin the practice and which are particularly adapted to specificenvironments and operative requirements, may be made to the describedembodiments without departing from the spirit and scope of the presentinvention. For example, various means may be used to attach the plateholder to the bone plate or to the drill guide assembly. In addition,the plate may be of various thicknesses, shapes, and contours; and havevarious fixation hole configurations. Accordingly, it should beunderstood that the embodiments disclosed herein are merely illustrativeof the principles of the invention. Various other modifications may bemade by those skilled in the art which will embody the principles of theinvention and fall within the spirit and the scope thereof.

1. A method of inserting a bone screw comprising the steps of: (a) providing a drill guide including a shaft having a front end, a rear end, and a bore therethrough, and a housing having a proximal end, a distal end and an alignment portion, the proximal end being coupled to the shaft, the housing further including a slot extending from the distal end of the housing to form a gap between the distal end of the housing and the distal end of the shaft, the slot terminating in an enlarged opening, and providing a bone plate having a first fixation hole for receiving a bone screw, a first drill guide key and a first retention mechanism for engaging a first bone screw; (b) associating the drill guide with the plate at a desired angle including: fixedly engaging the first guide key with the alignment portion; and inserting an outer diameter of the front end of the shaft within a diameter of the first fixation hole, wherein the first fixation hole diameter is larger than the outer diameter, and aligning the bore with the first fixation hole without fixedly associating the front end with the plate; and contacting the front end of the shaft with a top surface of the first retention mechanism; (c) inserting an instrument into the bore; (d) removing the instrument from the bore; (e) inserting a bone screw into the bore; and (f) engaging the first bone screw with the first retention mechanism without substantially displacing the drill guide relative to the bone plate.
 2. The method of claim 1, wherein the alignment portion is offset from the front end.
 3. The method of claim 2, wherein the alignment portion is configured to engage the bone plate proximate the first fixation hole.
 4. The method of claim 1, wherein the front end is not fixedly attached to the bone plate in steps (b)-(f).
 5. The method of claim 1, wherein step (c) further comprises drilling a bore into a bone surface suitable for receiving at least a portion of the bone screw.
 6. The method of claim 1, wherein the drill guide further comprises a handle, and wherein step (b) further comprises manipulating the handle to achieve the desired angle.
 7. The method of claim 1, further comprising the steps of disengaging the drill guide from the bone plate, associating the drill guide with the bone plate at a different location and inserting a second bone screw into a second fixation hole. 